71 Participants NeededMy employer runs this trial

Cord Blood Transplantation for Blood Cancer

Recruiting at 6 trial locations
AS
JJ
Overseen ByJaap Jan Boelens, MD, PhD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of cord blood transplants for treating blood cancer in children and young adults. Researchers aim to determine how well this method works as either the first or second transplant option. The trial includes two groups: one for patients with high-risk blood cancer who haven't had a transplant yet, and another for those who need a second transplant due to disease recurrence. Ideal participants have specific types of blood cancer and no suitable donor available within four weeks. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that Cord Blood Transplantation is likely to be safe for humans?

Studies have shown that Cord Blood Transplantation (CBT) is generally well-tolerated in patients with blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Research indicates that CBT can lead to higher overall survival rates compared to some other treatments. Specifically, one study found that patients receiving CBT had better survival outcomes and a lower chance of cancer recurrence.

However, some risks exist. For instance, a study found that while CBT reduced the chance of cancer returning, it also increased the risk of death from non-cancer-related causes. This suggests that although the cancer might not return, other risks are involved.

Overall, the data suggests that CBT is a promising option with a good safety record, though it comes with its own set of risks. Discussing these details with healthcare providers is crucial to understanding what this means for individual circumstances.12345

Why do researchers think this study treatment might be promising for blood cancer?

Cord blood transplantation is unique because it utilizes stem cells from umbilical cord blood, offering an alternative for patients who lack a suitable human leukocyte antigen (HLA)-matched donor. Unlike traditional bone marrow transplants, cord blood is more readily available and can be used even when perfect donor matches aren't found, providing a crucial option for patients with high-risk and very high-risk blood cancers. Researchers are excited about this approach because it may allow for transplants in cases where conventional donor sources aren't accessible, potentially increasing survival rates for patients with aggressive forms of blood cancer.

What evidence suggests that Cord Blood Transplantation could be an effective treatment for blood cancer?

Research has shown that cord blood transplants can effectively treat blood cancers like acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). In this trial, participants in Cohort 1, who have high-risk disease and are in complete remission, will receive cord blood transplants. Studies have found that cord blood transplants often lead to better chances of remaining cancer-free and lower recurrence rates compared to other donor types. For patients with high-risk AML, cord blood transplants are associated with significantly lower relapse rates and improved chances of living longer without disease progression. Participants in Cohort 2, who have very high-risk disease and may have had prior transplants, will also receive cord blood transplants. Specifically, another study found that AML and MDS patients who received cord blood transplants had relatively high long-term survival rates. Overall, cord blood transplants have demonstrated excellent results, making them a promising option for those needing a transplant.56789

Who Is on the Research Team?

AS

Andromachi Scaradavou, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and young adults with high-risk blood cancers like leukemia, lymphoma, or myelodysplastic syndrome. Participants may have needed multiple treatments to reach remission or have certain genetic risks. They must be in remission with low cancer cell counts before joining.

Inclusion Criteria

I developed AML or a myeloid neoplasm after treatment for another cancer or gene/cell therapy.
* Other high-risk features not defined above.
My diagnosis matches the required disease type for this study.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo Cord Blood Transplantation as the first or second transplant

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after transplantation

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Cord Blood Transplantation

Trial Overview

The study tests if cord blood transplantation—sometimes after strong chemotherapy and radiation—is effective as a first or second transplant for treating blood cancers in young people. Various drugs are used to prepare the body and prevent complications.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 2: Patients with Very High-Risk DiseaseExperimental Treatment10 Interventions
Group II: Cohort 1: Patients with High-Risk DiseaseExperimental Treatment10 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

T-cell replete cord transplants give superior outcomes in high ...

Compared with other cell sources, TRCB transplant results in improved disease-free survival and relapse risk in pediatric AML/MDS.

Cord Blood Transplantation versus Other Donor Sources in ...

Among patients with high-risk AML, CB transplantation was associated with significantly lower relapse and superior PFS compared to other donor ...

Evaluating the efficacy of umbilical cord blood transplantation ...

The 3-year OS for the entire cohort was 42.2% (95% CI: 21.8–61.3%). Among AML/MDS patients with TP53 mutations, a relatively high 3-year LFS ( ...

UCBT Yields Excellent Efficacy Outcomes in Hematologic ...

“Data from this prospective trial demonstrated excellent outcomes for cord blood transplant recipients receiving myeloablative conditioning ...

Cord Blood Transplantation versus Other Donor Sources in ...

Cord blood transplantation reduced relapse and improved progression-free survival. •. Our findings provide important insights into donor ...

Umbilical Cord Blood Transplantation Outcomes in Acute ...

These results suggest that UCBT is feasible in selected AML/MDS patients aged ≥70 years. In fact, UCBT shortens the required time for an unrelated donor search ...

Decisions, decisions: factors that impact HCT outcomes in ...

Understanding HCT transplant outcomes in AML depending on donor source, measurable pre-transplant disease, and conditioning regimen.

Cord Blood Transplantation Shows Superior Survival for ...

Patients who received CBT with uldMTX (CBT-uldMTX) achieved a significantly higher 2-year overall survival (OS) rate compared to patients who ...

Umbilical Cord Blood Transplantation Outcomes in Acute ...

Elderly AML patients who are treated may have better outcomes [1]; however, even in patients who achieve complete remission, their overall survival (OS) can ...